Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Implant Direct Recalled by Implant Direct Sybron Manufacturing LLC Due to Through a customer complaint and and internal investigation...

Date: October 11, 2019
Company: Implant Direct Sybron Manufacturing LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing LLC directly.

Affected Products

Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

Quantity: 78 implants

Why Was This Recalled?

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

Where Was This Sold?

This product was distributed to 22 states: AZ, AR, CA, GA, ID, IL, IN, KY, MD, MO, NV, NH, NJ, NY, ND, OR, PA, TX, UT, WA, WV, WI

Affected (22 states)Not affected

About Implant Direct Sybron Manufacturing LLC

Implant Direct Sybron Manufacturing LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report